Gelofusin (Solution) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Manufactured By

B. Braun Medical, AG (Switzerland)

ATC Code

B05AA06 (Gelatin preparations)

Active Substance

Gelatin (Ph.Eur. European Pharmacopoeia)

Dosage Form

Gelofusin

Infusion solution 4%: bot. 500 ml 10 pcs.

Dosage Form, Packaging, and Composition

Infusion solution transparent, light yellow.

* (weight-average molecular weight Mw 26500 daltons).

Excipients : sodium hydroxide – 1.36 g, water for injections – up to 1000 ml.

500 ml – low-density polyethylene bottles (10) – cardboard boxes (for hospitals).

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma-substituting medicinal product. It increases the circulating blood volume, which leads to an increase in venous return and cardiac output, an increase in blood pressure, and an improvement in the perfusion of peripheral tissues.

The increase in circulating blood volume and the rise in blood pressure occur not only due to the administered solution but also due to the additional influx of interstitial fluid into the vascular bed.

By causing osmotic diuresis, it helps maintain kidney function during shock. It reduces blood viscosity and improves microcirculation.

Due to its colloid-osmotic properties, it prevents or reduces the likelihood of interstitial edema development. It does not impair the protein, carbohydrate, or pigment functions of the liver; improves microcirculation; accelerates the erythrocyte sedimentation rate, which normalizes on average after 20 days.

The volume-replacing effect lasts for 5 hours.

Pharmacokinetics

Rapidly leaves the bloodstream, which is explained by the presence of a large number of low-molecular-weight fractions (after 2 hours, about 20% of the administered drug remains in the blood).

The elimination half-life (T_1/2) is 9 hours. 75% of the administered substance is excreted by the kidneys, 15% through the intestines.

10% of the gelatin is broken down in the tissues via proteolysis and is incorporated into protein metabolism. It does not accumulate.

Indications

Prevention and treatment of hypovolemia in cases of traumatic, burn, hemorrhagic, and toxic shock; conditions accompanied by blood thickening (for the purpose of hemodilution); extracorporeal circulation; prevention of blood pressure decrease during spinal or epidural anesthesia.

As a solvent for insulin administration (to reduce its losses due to adsorption on the walls of infusion containers and tubes).

ICD codes

Dosage Regimen

The dosage regimen is established individually, taking into account the severity of the plasma volume deficit.

It should be administered intravenously by drip. The duration of infusion and the volume of the administered solution are determined based on the dynamics of heart rate, blood pressure, diuresis, and the state of peripheral tissue perfusion.

For moderate blood loss and for prophylactic purposes in the preoperative period or during surgery, administer at a dose of 0.5-1 L over 1-3 hours.

For the treatment of severe hypovolemia – 1-2 L.

In emergency, life-threatening situations, administer 500 ml as a rapid infusion (under pressure), then, after improvement of circulation parameters, the infusion is continued in an amount equivalent to the volume deficit.

For maintaining circulating blood volume in shock, the infusion volume can reach 10-15 L/day.

For extracorporeal circulation, 0.5-1.5 L of solution is required (depending on the system used).

Adverse Reactions

From the cardiovascular system: hypocoagulation caused by a dilution effect (with a large infusion volume).

Allergic reactions: anaphylactoid reactions.

Contraindications

Hypervolemia, severe chronic heart failure, hypersensitivity to gelatin.

Use with caution in cases of hyperhydration, chronic renal failure, hemorrhagic diathesis, pulmonary edema, hypokalemia, hyponatremia.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is only possible if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Use in Renal Impairment

Use with caution in chronic renal failure.

Geriatric Use

The degree of hematocrit reduction after administration of the drug should not exceed 25% in elderly patients.

Special Precautions

The administration of gelatin can alter the parameters of diagnostic tests for glucose, fructose, cholesterol, fatty acids, as well as the erythrocyte sedimentation rate, specific gravity of urine, and urine protein indicators (including the biuret method).

If more than 2-3 L of solution is administered during surgery, the serum protein concentration should be monitored in the postoperative period, especially in the presence of tissue edema (if necessary, for further plasma-substituting therapy, the administration of human albumin is advisable).

The degree of hematocrit reduction after administration of the drug should not exceed 25% (in elderly patients, as well as in cases of cardiovascular and pulmonary insufficiency – 30%).

In chronic heart failure, the infusion should be performed slowly due to the possible circulatory overload.

When used as a pressure infusion (using a blood pressure cuff, infusion pump), the solution must be warmed to body temperature. When administering the drug under pressure, all air should be removed from the bottle beforehand.

Drug Interactions

Pharmaceutically incompatible with fat emulsions, barbiturates, muscle relaxants, antibiotics, glucocorticosteroids. Compatible with electrolyte solutions, carbohydrates, whole blood preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.